The Natural Resources Defense Council (NRDC) has filed a lawsuit against the Food and Drug Administration (FDA) and the Center for Veterinary Medicine (CVM) alleging that they have failed, in response to a Freedom of Information Act (FOIA) request, to produce documents pertaining to risk assessments for antibiotics used in livestock production. NRDC v. FDA, No. 12-4757 (S.D.N.Y., filed June 18, 2012). Seeking a declaration that the defendants violated FOIA and an order that they disclose “all responsive, non-exempt records to plaintiff within fifteen days,” NRDC refers to industry guidance that FDA issued in 2003 on “assessing the safety of antimicrobial new animal drugs with regard to the microbiological effects on bacteria of human health concern” and actions the defendants have taken since then relying on the guidance. After FDA acknowledged in a December 2011 Federal Register notice that it had begun “to look at the safety of some .…
Category Archives Food and Drug Administration
The Food and Drug Administration (FDA) has notified Representative Edward Markey (D-Mass.) that it has accepted his petition seeking to prohibit the use of bisphenol A (BPA) in canned infant formula. If the agency is able to complete its scientific review, it will file his petition in the Federal Register within 90 days seeking public comment on whether the industry has actually abandoned this use of the chemical, the ground on which Markey sought the ban. As noted in Issue 433 of this Update, while FDA has confirmed the chemical’s safety for continued use in food-packaging materials, the American Chemistry Council has asked the agency to prohibit its use in polycarbonate bottles and sippy cups, contending that industry no longer uses BPA in these products. Markey’s petition echoed that rationale in relation to infant-formula packaging. According to a news source, the “abandonment” focus allows government to “sidestep the debate over…
A federal court in New York has determined that the Food and Drug Administration (FDA) arbitrarily denied petitions filed by advocacy organizations in 1999 and 2005 requesting the initiation of proceedings to withdraw approval from certain uses of antibiotic drugs in livestock. Nat. Res. Defense Council v. FDA, No. 11-3562, (S.D.N.Y., decided June 1, 2012). The ruling follows the court’s March 2012 grant of summary judgment to the plaintiffs on their first claim for relief. Additional information about that ruling appears in Issue 432 of this Update. The most recent ruling relates to the third claim for relief, that is, whether FDA violated the Administrative Procedure Act when it denied the two petitions “requesting that the FDA withdraw approval of certain uses of certain classes of antibiotics in food-producing animals.” The court first determined that it had subject matter jurisdiction over the claim, disagreeing with FDA’s assertion that its November 2011 decision…
The Food and Drug Administration (FDA) has rejected a Corn Refiners Association (CRA) petition urging the authorization of “corn sugar” as an alternate name for high-fructose corn syrup (HFCS). According to FDA’s May 30, 2012, response, CRA had asked the agency (i) “to amend the generally recognized as safe (GRAS) affirmation regulation for HFCS (21 CFR 168.11) to designate ‘corn sugar’ as an optional name for HFCS”; (ii) “to eliminate ‘corn sugar’ as an alternate name for dextrose”; and (iii) “to replace all references to ‘corn sugar’ with ‘dextrose’” in the GRAS regulations for corn sugar (21 CFR 184.1857). The trade association had apparently argued, among other things, that consumers confused by the name “high-fructose corn syrup” “incorrectly believe that HFCS is significantly higher in calories, fructose and sweetness than sugar.” In rejecting the petition, FDA countered that its regulations define sugar as “a solid, dried, and crystallized food; whereas…
The Food and Drug Administration (FDA) has announced a public meeting titled “International Capacity Building with Respect to Food Safety.” Scheduled for June 19, 2012, in Washington, D.C., the meeting will highlight “FDA’s comprehensive plan to expand the technical, scientific, and regulatory capacity of foreign governments and their respective food industries in countries that export foods to the United States.” Under the auspices of the Food Safety Modernization Act, the capacity-building plan seeks input from food industry representatives, federal and foreign government officials, consumer organizations, and other stakeholders. The plan seeks (i) “[r]ecommendations for bilateral and multilateral arrangements and agreements, including providing for responsibilities of exporting countries to ensure food safety”; (ii) “[p]rovisions for secure electronic data sharing”; (iii) “[p]rovisions for mutual recognition of inspection reports”; (iv) “[t]raining of foreign governments and food producers on U.S. requirements for safe food”; (v) “[r]ecommendations on whether and how to harmonize requirements under…
The Food and Drug Administration (FDA) has determined that it will neither conduct a hearing nor make any changes to its final rule on the use of irradiation in processing and handling food. According to the agency, “the objections do not justify a hearing or otherwise provide a basis for revoking the regulation,” issued in October 2000 in response to a petition filed by Caudill Seed Co. which sought a regulatory amendment allowing “the safe use of ionizing radiation to control microbial pathogens in seeds for sprouting.” So ruling, FDA rejected Public Citizen’s concerns that the agency failed to apply a 100-fold safety factor, the petitioner submitted no conventional animal toxicity studies on sprouts from irradiated seeds, the review memorandum contained unsubstantiated statements, and the nutritional adequacy of irradiated seeds is questionable, among other matters. See Federal Register, May 11, 2012.
The National Consumers League (NCL) has filed a formal complaint with the Food and Drug Administration (FDA), alleging that NuVal LLC’s point of purchase nutrition rating system is “inconsistent with FDA guidance statements and enforcement correspondence, federal nutrition programs, and recommendations from the Institute of Medicine (IOM).” Used by more than 1,600 grocery stores in 31 states, the NuVal system apparently scores products out of 100 total points, with more nutritious options garnering a higher rating. NCL has argued, however, that NuVal relies on “a proprietary, non-public algorithm that can lead to inconsistent scores that may confuse and mislead consumers,” and has asked FDA to issue a warning letter to the retail industry about its continued use. Citing an IOM report on nutrition rating systems that criticized NuVal’s formula, the NCL complaint contends that NuVal “runs afoul” of FDA Guidance on Point of Purchase Labeling, which stipulates that all such…
A federal grand jury in Illinois has brought criminal indictments against four individuals who allegedly distributed more than 110,000 pounds of Mexican cheese in the United States in 2007 despite Food and Drug Administration (FDA) “hold” orders and also allegedly “washed” cheese returned by dissatisfied customers by scraping off mold and fungus so it could be resold. United States v. Zurita, No. __ (N.D. Ill., indictment returned April 18, 2012). No illnesses or other public health issues were attributed to the adulterated cheese distribution in the six-count indictment. The charges involve three separate shipments of cheese from Mexico that FDA ordered to be held and then later ordered either “detained” or “refused” after testing revealed the presence of Salmonella, E. coli, alkaline phosphate (found in unpasteurized products), and Staphylococcus. The defendants allegedly conspired to distribute the shipments despite FDA orders not to do so. They also allegedly distributed cheese before inspection, failed…
The Food and Drug Administration (FDA) has released a report describing its efforts to ensure the safety of imported food, drugs, medical devices, and other regulated products. Titled “Global Engagement,” the report asserts that FDA-regulated products originate from more than 150 countries, 130,000 importers and 300,000 foreign facilities. According to FDA, food imports have grown each year from 2005 to 2011 by an average of 10 percent, with Americans consuming approximately half of their fresh fruits, 20 percent of fresh vegetables and 80 percent of seafood from imports. “As the volume of imported food increases, so too does the risk that some products will fail to meet FDA standards,” the report states. “The realities of the global marketplace add substantial challenges to FDA’s ability to protect U.S. consumers.” Among its strategies to ensure imported product safety, FDA said it uses portable instruments to screen products, collaborates with coalitions of regulators…
The Food and Drug Administration (FDA) recently published its second annual Reportable Food Registry (RFR) report summarizing information submitted by manufacturers, processors, packers and holders through the online Food Safety Portal from September 8, 2010, to September 7, 2011. Covering all human and animal food/feed regulated by FDA “except infant formula and dietary supplements,” RFR tracks “patterns of food and feed adulteration” to help FDA administer inspection resources more effectively. According to the report, FDA received 1,153 total entries in RFR’s second year compared with 2,600 in its first year, a difference which the agency ascribes to three major events in 2009-2010 that generated 1,284 subsequent records related to sulfites in prepared side dishes, Listeria monocytogenes in cheese spreads and Salmonella in hydrolyzed vegetable protein. Without these entries, FDA stated, the tallies for the first and second years would have differed by only 74 records. In particular, the second annual…
